- The NICE guidance reviewed two sensor-augmented
insulin pump therapy systems and recommends the MiniMed® Paradigm
Veo(TM) system for managing glucose levels in people with Type 1
diabetes.1
- The MiniMed Paradigm Veo and the MiniMed 640G
sensor-augmented insulin pump therapy systems can help to protect
against severe hypoglycemia in people with Type 1 diabetes by
continuously monitoring glucose levels.
- NICE concluded that the adoption of Medtronic
technology has the potential to save a UK health system £1,500 per
person per year.1
DUBLIN - February 12, 2016 -
Today, the United Kingdom's National Institute for
Health and Care Excellence (NICE) has issued positive guidance
for the use of Medtronic insulin pump systems integrated with
glucose sensors, for managing Type 1 diabetes and the avoidance of
potentially life-threatening hypoglycemic episodes.1,
2
The guidance reviewed two sensor-augmented insulin
pump therapy systems and recommends the MiniMed Paradigm Veo system
for managing glucose levels in people with Type 1 diabetes who
experience 'disabling hypoglycemia' - defined as repeated and
unpredictable occurrence of low-blood sugar attacks that result in
persistent anxiety about recurrence, and is associated with a
significant adverse impact on quality of life.1
Since the assessment of the MiniMed Paradigm Veo
system in the Diagnostics Assessment Programme (DAP), NICE has
recognised that in 2015, Medtronic launched a successor system,
MiniMed 640G.3
Type 1 diabetes is an autoimmune condition in
which the pancreas does not produce any insulin.4 It is a
chronic, life-threatening condition that is on the increase. It
currently affects around 400,000 people in the UK - 32,500 of whom
are children.5
A hypoglycemic episode, also known as a 'hypo', is
triggered when a person's blood glucose levels are too
low.2 The average
individual with Type 1 diabetes suffers approximately two hypos
every week.6 Symptoms
including sweating, fatigue, and dizziness, and in severe cases
they can lead to seizures, loss of consciousness, and even
death.2 A hypo can be
dangerous if not treated immediately and because they often go
undetected, night-time hypos can be of particular concern to
patients and to parents of children living with
diabetes.7
The MiniMed Paradigm Veo and MiniMed 640G systems,
the only systems to offer low glucose suspend mode, both
incorporate continuous glucose monitoring (CGM) technology,
providing users with a more complete picture of their glucose
levels. The system alerts users when their sensor glucose levels
are falling too low or rising too high, and also mimics the human
pancreas' ability to suspend insulin delivery automatically -
protecting against the risk of ahypo, even when a person is asleep
or unable to react.
Adopting the MiniMed Paradigm Veo system may
result in the following potential savings:
-
£1,500 per person per annum from reduced
on-going costs compared to using a stand-alone continuous glucose
monitor with an insulin pump (CSII)
-
£300-£1,600 for each avoided hospital admission
for diabetes with hypoglycemic disorders
-
£80-£240 for each avoided Accident &
Emergency attendance
-
£180 and £230 per ambulance call per
patient.8
Commenting on the guidance, Consultant
Diabetologist of Harrogate District Hospital and ex-Clinical Lead
for the NHS Diabetes National Insulin Pump Network, Peter Hammond,
stated: "Avoiding episodes of severe or disabling hypoglycemia
(hypos) can be one of the biggest challenges associated with
managing Type 1 diabetes. Preventing hypoglycemic attacks, which
put the lives of patients at risk and lead to costly A&E
admissions and hospitalization, is a priority area for the NHS. The
Medtronic system recommended by NICE incorporates sensor
technology, continuously monitoring sugar and shutting-off insulin
when needed, to reduce the risk of a hypo. Insulin pump therapy
systems combined with continuous glucose sensing and automated
suspension of insulin delivery can be a lifesaver for those who
have lost the ability to recognise when they are experiencing a
hypoglycemic episode, and are also very reassuring for parents of
children with Type 1 diabetes who fear night-time hypoglycemia.
This guidance is extremely positive; acknowledging the latest
technology and confirming the vital role of sensor-augmented
insulin pump therapy with automated insulin suspend in the
effective treatment of Type 1 diabetes today."
"This guidance is a great step forward for
ensuring that people with Type 1 diabetes have easier access to the
latest technology, which will help those that meet the criteria
manage their condition better," said Lesley Jordan, pump user and
chief executive of UK Patient Advocacy Group INPUT. "CGM
continuously monitors the glucose and alerts the user when the
glucose level goes out of the safe range; and low glucose suspend
helps prevent the glucose level from dropping dangerously low,
which can result in collapse, coma or death. The availability of
such advanced technology means those living with Type 1 diabetes
may experience less difficulty and risk in their day-to-day lives
as a result."
This diagnostics guidance supports the use of the
MiniMed Paradigm Veo system for managing glucose levels in people
with Type 1 diabetes if:
- they have episodes of disabling hypoglycemia
despite optimal management with continuous subcutaneous (under the
skin) insulin infusion and
- Medtronic arranges to collect, analyse and
publish data on the use of the MiniMed Paradigm Veo system and
successor technologies with low-glucose suspend
function.1
Note to Editors
In accordance with the recommendations, Medtronic will collect,
analyse and publish data on the MiniMed Paradigm Veo, MiniMed 640G,
and successive generation systems. The data and associated
publications will contribute towards future Diagnostic Guidance
updates and will include MiniMed 640G. Registration and data
uploads will continue to be optional for the patient.
The guidance also requires that the MiniMed
Paradigm Veo system should be used under the supervision of a
trained multidisciplinary team who are experienced in continuous
subcutaneous insulin infusion and continuous glucose monitoring,
for managing Type 1 diabetes, if the person or the care-giver:
- agrees to use the sensors for at least 70% of the
time
- understands how to use it and is physically able
to use the system and
- agrees to use the system while having a
structured education programme on diet and lifestyle, and
counselling.
About the NICE DAP
Process
As part of NICE's work on evaluating medical technologies, the
Diagnostics Assessment Programme (DAP) focuses on the evaluation of
innovative medical diagnostic technologies in order to ensure that
the NHS is able to adopt clinically and cost effective technologies
rapidly and consistently.9
About NICE Medtech Innovation
Briefings
NICE Medtech Innovation Briefings (MIBs) are designed to support
NHS and social care commissioners and staff who are considering
using new medical devices and other medical or diagnostic
technologies. The information provided includes a description of
the technology, how it's used and its potential role in the
treatment pathway, as well as a review of relevant published
evidence and the likely costs of using the technologies. MIBs are
designed to be fast, flexible and responsive to the need for
information on innovative technologies.10
About the MiniMed Paradigm Veo
System
Launched by Medtronic in the UK in 2009, the MiniMed Paradigm Veo
system combines insulin pump therapy and CGM with a unique
capability to automatically suspend insulin delivery temporarily if
glucose levels become too low, protecting against the risk of
hypoglycemia even when a person is asleep or unable to react.
The system includes an insulin pump with CGM
provided by means of a separate sensor and transmitter. The patient
uses readings from the monitor in conjunction with occasional
confirmatory fingerstick measurements to understand their current
glucose level, and program the insulin pump to deliver the
appropriate amount of insulin. If data transmitted from the sensor
show that the patient's glucose levels have dropped below a defined
threshold, the insulin pump automatically suspends insulin delivery
for up to two hours, to help protect against hypoglycemic
events.
About the MiniMed 640G
System
Launched in the UK in 2015, the MiniMed 640G system is designed to
help people with diabetes achieve better glucose control through
advanced protection from hypoglycemia. With first-of-its-kind
SmartGuard(TM) technology, the system is the first in the world to
both automatically suspend insulin delivery when sensor glucose
levels are predicted to approach a low limit and resume insulin
delivery once sensor glucose levels recover. The system includes
the Enhanced Enlite(TM) sensor, which continuously monitors glucose
levels with accuracy and comfort. It also incorporates an updated
insulin pump design to provide convenient diabetes management with
a simple user interface, full-colour screen, waterproofing and
remote bolus.
About the Diabetes Group at
Medtronic (www.medtronicdiabetes.com)
Medtronic is working together with the global community to change
the way people manage diabetes. The company aims to transform
diabetes care by expanding access, integrating care and improving
outcomes, so people living with diabetes can enjoy greater freedom
and better health.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
1 NICE
Published Guidance http://www.nice.org.uk/guidance/dg21
2 Diabetes.co.uk:
Diabetes and Hypoglycaemia.
http://www.diabetes.co.uk/Diabetes-and-Hypoglycaemia.html Last
accessed February 2016
3 NICE
Published Guidance http://www.nice.org.uk/guidance/dg21
4 NHS
Choices. Type 1 Diabetes.
http://www.nhs.uk/Conditions/Diabetes-type1/Pages/Causes.aspx Last
accessed February 2016
5 Daily
Hansard - Westminster Hall. Type 1 Diabetes (Young People). 30
April 2014 : Column 247WH
http://www.publications.parliament.uk/pa/cm201314/cmhansrd/cm140430/halltext/140430h0001.htm
Last accessed February 2016
6 McCrimmon,
RJ and Sherwin, RS. Hypoglycemia in Type 1 Diabetes. Diabetes 2010;
59(10): 2333-2339
7 Nocturnal
Hypoglycemia: Answering the Challenge With Long-acting Insulin
Analogs. Medical General Medicine. 2007; 9(2):
38. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1994862/ Last
accessed February 2016
8 NICE
Resource Impact Report
http://www.nice.org.uk/guidance/dg21/resources/resource-impact-report-2312936173
9 NICE
diagnostics guidance:
https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-diagnostics-guidance
Last accessed February 2016
10 Medtech
innovation briefings:
https://www.nice.org.uk/about/what-we-do/our-programmes/nice-advice/medtech-innovation-briefings
Last accessed February 2016
Contacts:
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Public Relations
+1-818-576-3398
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Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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